Pulmonary Disease, Chronic ObstructiveNCT01058486
Multicomponent Intervention to Decrease Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations
A study testing Self-Management and Motivational Interviewing in people with Pulmonary Disease, Chronic Obstructive, run by Mayo Clinic at 2 sites in United States.
Trial summary
The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Self-Management and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥40 years old
- Clinical diagnosis of COPD or pulmonary function testing reflecting an FEV1/FVC ratio of <0.70
- Current or previous smoker with at least 10 pack-years of cigarette smoking
- Recently hospitalized for an exacerbation of COPD
Who cannot join
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency, are planning to move out of the state, are not living in the healthcare area, or have no telephone at home).
- Patents with characteristics that can confound the analysis of the primary outcome (patients who are living in a nursing home, have unresectable lung cancer, or have another advanced neoplasm).
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
- Patients with an inability to do mild exercise, such as cycling or walking, when their COPD is stable (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55902
Regions Hospital
Saint Paul, Minnesota, 55101
About this study
Official title: Multicomponent Intervention to Decrease COPD-related Hospitalizations
The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.
In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.
This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Self-Management and Motivational Interviewing
- Keywords
- Chronic Disease Management, Physical Activity, Self-efficacy, Self management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management and Motivational InterviewingBehavioural
Post hospital discharge, patients will be referred (<2 weeks) to pulmonary rehabilitation (PR) (1-2 sessions per week for 6-8 weeks). PR visits (approximately 1 hour) will include education, strengthening and endurance exercise as the patient tolerates.
A counselor (RN or RRT) and patient will meet once weekly after PR session. The counselor will assess the patient's self efficacy and knowledge of self-management principles of COPD. Based on the assessment and greatest needs identified by patient, the counselor will work with the participant to collaboratively develop a specific SM plan.Motivational interviewing techniques will be used.
Following completion of PR, the counselor will contact the patient monthly to provide clinical support on SM of COPD. To ensure consistency of intervention, we will use standardized treatment procedures and phone scripts.
| Study group | Role | What they receive |
|---|---|---|
| Activity-Self Management | Experimental | Not described Receives: Behavioral: Self-Management and Motivational Interviewing |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group .
"a priori" measure as funded by NIH
Measured: 12 months
To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group.
Measured: 12 months
Secondary outcomes (1)
To determine the impact of the intervention on self efficacy for physical activity and disease management, physical activity level and active energy expenditure, and health-related quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, M.D., MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058486
- Sponsor's protocol ID
- 09-004341
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benzo R, McEvoy C. Effect of Health Coaching Delivered by a Respiratory Therapist or Nurse on Self-Management Abilities in Severe COPD: Analysis of a Large Randomized Study. Respir Care. 2019 Sep;64(9):1065-1072. doi: 10.4187/respcare.05927. Epub 2019 Mar 26.
PubMed 30914491Benzo R, Vickers K, Novotny PJ, Tucker S, Hoult J, Neuenfeldt P, Connett J, Lorig K, McEvoy C. Health Coaching and Chronic Obstructive Pulmonary Disease Rehospitalization. A Randomized Study. Am J Respir Crit Care Med. 2016 Sep 15;194(6):672-80. doi: 10.1164/rccm.201512-2503OC.
PubMed 26953637Benzo R, Wetzstein M, Neuenfeldt P, McEvoy C. Implementation of physical activity programs after COPD hospitalizations: Lessons from a randomized study. Chron Respir Dis. 2015 Feb;12(1):5-10. doi: 10.1177/1479972314562208. Epub 2014 Dec 15.
PubMed 25511306
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Intervention to Decrease COPD-related Hospitalizations
- ClinicalTrials.gov ID
- NCT01058486
- Acronym / sponsor ID
- 09-004341
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Disease Management, Physical Activity, Self-efficacy, Self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- HealthPartners Institute
- Study start
- Sep 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.
In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.
This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity-Self Management | Experimental | Behavioral: Self-Management and Motivational Interviewing |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be ≥40 years old
- Clinical diagnosis of COPD or pulmonary function testing reflecting an FEV1/FVC ratio of <0.70
- Current or previous smoker with at least 10 pack-years of cigarette smoking
- Recently hospitalized for an exacerbation of COPD
Key exclusion criteria (4 listed)
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency, are planning to move out of the state, are not living in the healthcare area, or have no telephone at home).
- Patents with characteristics that can confound the analysis of the primary outcome (patients who are living in a nursing home, have unresectable lung cancer, or have another advanced neoplasm).
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
- Patients with an inability to do mild exercise, such as cycling or walking, when their COPD is stable (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management and Motivational InterviewingPost hospital discharge, patients will be referred (<2 weeks) to pulmonary rehabilitation (PR) (1-2 sessions per week for 6-8 weeks). PR visits (approximately 1 hour) will include education, strengthening and endurance exercise as the patient tolerates. A counselor (RN or RRT) and patient will meet once weekly after PR session. The counselor will assess the patient's self efficacy and knowledge of self-management principles of COPD. Based on the assessment and greatest needs identified by patient, the counselor will work with the participant to collaboratively develop a specific SM plan.Motivational interviewing techniques will be used. Following completion of PR, the counselor will contact the patient monthly to provide clinical support on SM of COPD. To ensure consistency of intervention, we will use standardized treatment procedures and phone scripts. | Behavioural | Activity-Self Management |
Primary outcome
To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group .
Time frame: 12 months
"a priori" measure as funded by NIH
To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group.
Time frame: 12 months
1 secondary outcome
To determine the impact of the intervention on self efficacy for physical activity and disease management, physical activity level and active energy expenditure, and health-related quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 30914491Benzo R, McEvoy C. Effect of Health Coaching Delivered by a Respiratory Therapist or Nurse on Self-Management Abilities in Severe COPD: Analysis of a Large Randomized Study. Respir Care. 2019 Sep;64(9):1065-1072. doi: 10.4187/respcare.05927. Epub 2019 Mar 26.
- Derived from this study: PubMed 26953637Benzo R, Vickers K, Novotny PJ, Tucker S, Hoult J, Neuenfeldt P, Connett J, Lorig K, McEvoy C. Health Coaching and Chronic Obstructive Pulmonary Disease Rehospitalization. A Randomized Study. Am J Respir Crit Care Med. 2016 Sep 15;194(6):672-80. doi: 10.1164/rccm.201512-2503OC.
- Derived from this study: PubMed 25511306Benzo R, Wetzstein M, Neuenfeldt P, McEvoy C. Implementation of physical activity programs after COPD hospitalizations: Lessons from a randomized study. Chron Respir Dis. 2015 Feb;12(1):5-10. doi: 10.1177/1479972314562208. Epub 2014 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto P Benzo, M.D., MSc principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management and Motivational Interviewing in people with Pulmonary Disease, Chronic Obstructive, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058486, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.